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Table 2 Potential risks and solutions for residents undertaking intervention

From: Myofunctional device use in oral care and swallowing: a protocol for a feasibility study in an aged care population

Potential risks

Solutions

Aspiration of saliva secondary to increased saliva production during device use.

Aspiration of saliva occurs daily. The continued use of usual oral care during this study to ensure adequate oral hygiene should assist with reducing complications that may arise from aspiration of saliva.

Monitoring by care staff to ensure participants have adequate salvia management/control, such as monitoring for coughing/voice change with device use.

If coughing occurs through the use of the device and increased saliva production, a referral will be made for review by the medical officer, as well as speech pathology at the ACF to review swallowing function (and appropriateness for continuation in the study).

Initial discomfort to gums/jaw with the action of chewing the device

The treatment intervention incorporates staged in time use of the device, increasing weekly to allow for adjustment to oral comfort. Supervision by care staff will be provided during the device use. If oral discomfort is identified/reported, a review by the researcher and speech pathologist at the ACF will take place and recommendations will be made regarding continuation in the study.

Sizing and selection of the device have been considered for oral comfort and ease, placing, and removing the device from the oral cavity with an eternal tab/handle.

Infection control

Infection control procedures are outlined in the treatment manual and are consistent with COVID 19 safety and cleaning measures. Staff will be trained in cleaning protocols for the device (which are not aerosol generated) to reduce the risk of infection. Daily cleaning will be tracked with the completion of a daily check list by care staff at the ACF.